2023 年第 11 期 第 18 卷

达格列净与二甲双胍对每日两次预混胰岛素注射治疗血糖未达标2型糖尿病患者血糖控制的影响

Effect of dapagliflozin and metformin for blood glucose control in type 2 diabetes mellitus with uncontrolled hyperglycemia treated with twice daily premixed insulin injection

作者：代肖1许奕航1马利双1唐颖1解丹丹1赵晓彤1许慕蓉1方朝晖2陈明卫1

英文作者：Dai Xiao1 Xu Yihang1 Ma Lishuang1 Tang Ying1 Xie Dandan1 Zhao Xiaotong1 Xu Murong1 Fang Zhaohui2 Chen Mingwei1

单位：1安徽医科大学第一附属医院内分泌科，合肥230032；2安徽中医药大学第一附属医院内分泌科，合肥230031

英文单位：1Department of Endocrinology the First Affiliated Hospital of Anhui Medical University Hefei 230032 China; 2Department of Endocrinology the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Hefei 230031 China

关键词：2型糖尿病；预混胰岛素；达格列净；二甲双胍；扫描式葡萄糖监测

英文关键词：Type2diabetesmellitus;Premixedinsulin;Dapagliflozin;Metformin;Flashglucosemonitoring

• 摘要：

• 目的  探讨达格列净与二甲双胍对每日两次预混胰岛素注射治疗血糖未达标2型糖尿病（T2DM）患者血糖控制的影响。方法  选取2021年4月至2022年4月在安徽医科大学第一附属医院内分泌科就诊的已接受预混胰岛素治疗的T2DM患者60例，于佩戴扫描式葡萄糖监测（FGM）系统1周后，按照随机数字表法分为联合达格列净治疗组（DAPA组，30例）和联合二甲双胍治疗组（MET组，30例），接受各自治疗方案12周，并在治疗的第11周结束时再次佩戴FGM 1周。比较2组治疗前后血糖相关指标及其变化值和安全性。结果  治疗后，DAPA组体质量、体重指数、葡萄糖波动水平（IQR）、低血糖持续时间（HopD）、胰岛素用量低于/短于MET组，目标范围内时间（TIR）高于MET组（均P＜0.05），2组空腹血糖、餐后2 h血糖、糖化血红蛋白、平均葡萄糖值水平比较差异均无统计学意义（均P＞0.05）。DAPA组ΔTIR高于MET组，Δ体质量、Δ体重指数、ΔIQR、ΔHpoD均低于/短于MET组（均P＜0.05）。协方差分析结果显示，治疗12周结束时TIR（F=7.282，P＜0.01）、IQR（F=6.934，P＜0.01）、HpoD（F=5.971，P＜0.01）均与治疗方案有关。DAPA组低血糖发生率低于MET组［13.3%(4/30)比36.7%(11/30)］，12周内血糖安全达标率高于MET组［60.0%(18/30)比33.3%(10/30)］（均P＜0.05）。结论  在每日两次预混胰岛素注射治疗血糖未达标的T2DM患者中，联合达格列净的降糖疗效不仅非劣效于联合二甲双胍治疗方案，还具有降低低血糖风险、避免体质量增加、降低血糖波动水平的优势。

• Objective  To investigate the effects of dapagliflozin and metformin for blood glucose control in type 2 diabetes mellitus (T2DM) with uncontrolled hyperglycemia treated with twice daily premixed insulin injection. Methods  A total of 60 T2DM patients admitted to Department of Endocrinology, the First Affiliated Hospital of Anhui Medical University from April 2021 to April 2022 were recruited. Patients had uncontrolled hyperglycemia treated with twice daily premixed insulin injection, and then they all wore flash glucose monitoring (FGM) for 1 week. Subsequently, they were divided into combined dapagliflozin group (DAPA group, 30 cases) and combined metformin group (MET group, 30 cases) according to random number table method, and received respective treatment regime for 12-week. At the end of the 11th week of treatment, all patients wore FGM again for 1 week until the end of the study. The blood glucose related indicators, indicator changes, and safety between the two groups before and after treatment were compared. Results  After treatment, the body mass, body mass index, glucose fluctuation level (IQR), duration of hypoglycemia (HopD), and insulin dosage in the DAPA group were lower/shorter than those in the MET group, while the time within the target range (TIR) was higher than that in the MET group (all P＜0.05). There were no statistically significant differences in fasting blood glucose, 2 h postprandial blood glucose, glycosylated hemoglobin, and mean blood glucose levels between the two groups (all P＞0.05). The ΔTIR of DAPA group was higher than that of the MET group, Δbody mass, Δbody mass index, ΔIQR, ΔHpoD of DAPA group were lower/shorter than those of the MET group (all P＜0.05). Analysis of covariance showed that TIR (F=7.282, P＜0.01), IQR (F=6.934, P＜0.01), HpoD (F=5.971, P＜0.01) at the end of 12 weeks of treatment were all related to the treatment scheme. The incidence of hypoglycemia in the DAPA group was lower than that in the MET group ［13.3%(4/30) vs 36.7%(11/30)］, and the rate of achieving safe blood glucose levels within 12 weeks was higher than that in the MET group ［60.0%(18/30) vs 33.3%(10/30)］(both P＜0.05). Conclusions    Combination with dapagliflozin therapy is not inferior to combination with metformin therapy for T2DM with uncontrolled hyperglycemia treated with twice daily premixed insulin injection. Moreover, combination with dapagliflozin therapy has the advantage of reducing hypoglycemia risk, avoiding body mass gain, and decreasing blood glucose fluctuations.